Pragmatic Trials

Ford, Ian; Norrie, John

doi:10.1056/nejmra1510059

Cited by 1,083 publications

(891 citation statements)

References 126 publications

(101 reference statements)

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“…16,17 Hence, on a practical basis, many trials have not adequately informed practice. 18 RCT limitations may include i) relatively small samples, ii) highly selected investigators, iii)…”

Section: Introductionmentioning

confidence: 99%

Clinical Perspective on Antihypertensive Drug Treatment in Adults With Grade 1 Hypertension and Low-to-Moderate Cardiovascular Risk: An International Expert Consultation

Salinas¹,

Coca

Olsen

et al. 2017

Current Problems in Cardiology

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“…16,17 Hence, on a practical basis, many trials have not adequately informed practice. 18 RCT limitations may include i) relatively small samples, ii) highly selected investigators, iii)…”

Section: Introductionmentioning

confidence: 99%

Clinical Perspective on Antihypertensive Drug Treatment in Adults With Grade 1 Hypertension and Low-to-Moderate Cardiovascular Risk: An International Expert Consultation

Salinas¹,

Coca

Olsen

et al. 2017

Current Problems in Cardiology

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“…But future efforts to improve family outcomes following critical care may be informed by corresponding efforts to improve outcomes for patients themselves, among whom considerable heterogeneity also exists. Specifically, the successful identification of interventions that improve family outcomes may require both large, pragmatic trials [13] and the development and incorporation of baseline indices of risk for adverse bereavement outcomes [14,15].…”

mentioning

confidence: 99%

Life after death in the ICU: detecting family-centered outcomes remains difficult

2017

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Family members of patients who die in the ICU experience significant and lasting psychological burdens, such as post-traumatic stress disorder (PTSD), anxiety, depression, and prolonged grief [1,2]. Among the many potential contributors to these adverse bereavement outcomes are the circumstances surrounding and processes of limiting life support. This hypothesis is supported by evidence that ICU deaths are commonly preceded by decisions to withdraw life support [3], and evidence that both ICU processes of care [4,5] and behaviors of ICU clinicians [1,6] near the end of life can influence family members' post-ICU psychological outcomes. Thus, uncertainty regarding which approaches to withdrawing mechanical ventilation are least distressing for patients and families [7,8] represents an important area for rigorous investigation.In this context, Reignier and colleagues performed a prospective observational cohort study to compare psychological symptoms in over 400 family members of patients who died after withdrawal of mechanical ventilation by immediate extubation vs. terminal weaning in 43 French ICUs [9]. Impressively, the authors were able to assess the primary endpoint of PTSD symptoms 3 months after death among over 95% of enrolled family members. Secondary endpoints included symptoms of anxiety, depression, and complicated grief among family members, symptom burdens of patients during the dying process, and strains on ICU staff.The authors found no differences between groups in any of the psychological outcomes reported by family members at 3 months. This was a durable finding when adjusted for patient characteristics and center effects, and at 6-and 12-month follow-up assessments. ICU staff experienced similar levels of job strain regardless of the withdrawal method chosen, with the exception of nursing assistants who reported less strain with immediate extubation. Patients in the immediate extubation group experienced more gasping and airway obstruction and received significantly lower doses, on average, of sedatives and analgesics compared to those undergoing terminal weaning. Given these results, the authors conclude that the choice between these two approaches to withdrawal of mechanical ventilation does not impact psychological symptoms among family members. They also suggest, and we agree, that standardized approaches to medication administration near the end of life may reduce patient suffering.This study is innovative in empirically evaluating the impact of how mechanical ventilation is withdrawn on family-centered outcomes. It is also strengthened by the diverse sample of ICUs, and the outstanding follow-up rate. However, the ability to draw conclusions is tempered by the non-randomized design. Although the authors appropriately note that randomly assigning ICUs to an unfamiliar withdrawal method might engender low adherence to the assigned interventions, the observational design amounts to a comparison of withdrawal methods on family members who chose (or whose clinicians chose for them) a particul...

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“…This problem appears largely unavoidable in this context. 2 An information intervention cannot plausibly be blinded, and the need to obtain consent to assess patient-reported outcomes would seem to imply that patients must know which arm they are in. However, the lack of statistical significance of several results suggests that future pragmatic trials of drug label changes should be implemented in settings that offer larger sample sizes than those obtained in this study.…”

mentioning

confidence: 99%

Capsule Commentary on Wolf et al., A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence

Smieliauskas

2016

J GEN INTERN MED

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Pragmatic Trials

Cited by 1,083 publications

References 126 publications

Clinical Perspective on Antihypertensive Drug Treatment in Adults With Grade 1 Hypertension and Low-to-Moderate Cardiovascular Risk: An International Expert Consultation

Clinical Perspective on Antihypertensive Drug Treatment in Adults With Grade 1 Hypertension and Low-to-Moderate Cardiovascular Risk: An International Expert Consultation

Life after death in the ICU: detecting family-centered outcomes remains difficult

Capsule Commentary on Wolf et al., A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence

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